What side effects are associated with this type of intervention?

Common treatments for Interstitial Lung Disease (ILD) that enhance blood flow and oxygen delivery, such as inhaled nitric oxide (INO) and inhaled treprostinil, have known side effects. INO can cause headache, dizziness, and methemoglobinemia. Inhaled treprostinil may lead to headache, cough, dyspnea, dizziness, nausea, fatigue, and diarrhea. These treatments aim to improve oxygenation and exercise tolerance, similar to the potential benefits of nitrate-rich beetroot juice.

What prior FDA approvals exist?

FDA-approved treatments for Interstitial Lung Disease (ILD) include pirfenidone and nintedanib, which are antifibrotic agents that slow disease progression. While these drugs do not specifically enhance blood flow and oxygen delivery to muscles, they have shown benefits in lung function and reducing acute exacerbations. There is no direct mention of FDA-approved treatments that improve exercise performance through mechanisms similar to nitrate-rich beetroot juice in the provided context.

What other types of research exist?

Promising alternatives to nitrate-rich beetroot juice for ILD patients include established treatments like pirfenidone and nintedanib, which improve lung function and reduce disease progression. Additionally, structured pulmonary rehabilitation programs remain crucial. Ongoing research may introduce new therapies or supplements that enhance exercise performance by improving blood flow and oxygen delivery to muscles.

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Dietary Supplement

Beetroot Juice for Interstitial Lung Disease

N/A

Waitlist Available

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinically stable for the preceding 6 weeks

A multidisciplinary diagnosis of idiopathic pulmonary fibrosis (IPF), idiopathic fibrotic nonspecific interstitial pneumonia (NSIP), chronic hypersensitivity pneumonitis (HP), or unclassifiable ILD with a differential diagnosis that consists of the above diagnoses

Must not have

Contraindication to exercise testing (e.g. significant cardiovascular, musculoskeletal, neurological disease) (see Table 4 from ERS/ATS consensus statement)

Use of prednisone >10 mg/day for >2 weeks within 3 months of the first study visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week

Summary

This trial is testing if drinking beetroot juice with high nitrate levels can help people with a type of lung disease exercise better. The target group is patients with a type of lung disease, who have difficulty breathing and exercising. The nutrients in the beetroot juice help improve blood flow and muscle function, which may make it easier for these patients to exercise. Beetroot juice, rich in nutrients, has been shown to improve exercise performance and muscle efficiency in various populations.

Who is the study for?

This trial is for people with certain types of interstitial lung disease (like IPF or NSIP) who have stable oxygen levels and health in the past 6 weeks. They should be able to exercise, not have severe other diseases, no pacemakers or similar devices, and their lung function should be above a specific threshold.

What is being tested?

The study tests if drinking beetroot juice rich in nitrate improves exercise performance compared to beetroot juice without nitrate for those with interstitial lung disease. Participants will drink one type of juice and see how it affects their ability to exercise.

What are the potential side effects?

Beetroot juice may cause changes in urine color, digestive discomfort, or lower blood pressure. Since it's a natural product used within normal dietary amounts, serious side effects are unlikely but can vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My health condition has been stable for the last 6 weeks.

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I have been diagnosed with a specific type of lung scarring disease by a team of doctors.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot do exercise tests due to a serious health condition.

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I have not taken more than 10 mg/day of prednisone for over 2 weeks in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in submaximal cycle exercise endurance time following dietary nitrate supplementation compared to placebo supplementation.

Secondary study objectives

Difference in concentration of plasma nitrate ([NO3-]) and nitrite ([NO2-]) following dietary nitrate supplementation compared to placebo supplementation.

Difference in exertional dyspnoea during activities of daily living following dietary nitrate supplementation compared to placebo supplementation.

Difference in exertional dyspnoea during submaximal cycle exercise following dietary nitrate supplementation compared to placebo supplementation.

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Dietary nitrate supplementationExperimental Treatment1 Intervention

The dietary nitrate supplement will be a concentrated, nitrate-rich beetroot juice (70 ml providing ∼400mg nitrate per serving)

Group II: PlaceboPlacebo Group1 Intervention

The placebo will be a concentrated, nitrate-depleted beetroot juice (70 ml with trace amounts of nitrate)

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Interstitial Lung Disease (ILD) include antifibrotic agents like nintedanib and pirfenidone, which slow disease progression by inhibiting pathways that lead to fibrosis. Immunosuppressive drugs such as corticosteroids and methotrexate reduce inflammation and immune response. Pulmonary rehabilitation, including exercise training, improves overall physical function and quality of life. Nitrate-rich beetroot juice, currently under study, enhances blood flow and oxygen delivery to muscles, potentially improving exercise performance. These treatments are crucial for ILD patients as they address the core issues of inflammation, fibrosis, and reduced exercise capacity, thereby improving symptoms and slowing disease progression.

[Experimental chronic paraquat poisoning. Functional and histopathological pulmonary changes].Nilotinib ameliorates lipopolysaccharide-induced acute lung injury in rats.NOX4/NADPH oxidase expression is increased in pulmonary fibroblasts from patients with idiopathic pulmonary fibrosis and mediates TGFbeta1-induced fibroblast differentiation into myofibroblasts.